FDA Watch List: Incivek

The Food and Drug Administration released its most recent list of drugs that consumers and health professionals should keep their eye on due to serious risks or new safety information.

One of the drugs on this quarterly list includes Incivek (Telaprevir), which is used to treat hepatitis C (HCV) —a viral disease that causes inflammation of the liver, according to the National Center for Biotechnology Information.

Incivek is on the watch list because it is linked to serious skin reactions such as Drug Reaction with Eosinophilia and Systematic Symptoms (DRESS) and Stevens Johnson Syndrome (SJS). SJS is a rare and debilitating disorder that affects mucous membranes and the skin. The FDA is evaluating this issue to determine if regulatory action is necessary.

The FDA used the information from the Adverse Event Reporting System (AERS) database from October to December 2011 to identify the new hazards and safety data for the drugs. An appearance of a medication on the list is an indication that there is a potential safety issue, but does not mean there is a cause and effect relationship between the drug and risk.

If you or a loved one has been harmed by a dangerous drug, contact Sokolove Law for a free legal consultation and to find out if a dangerous drug lawyer may be able to help you. For legal help, call (877) 490-6520.

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